Heart disease and stroke are the main cause of death in the United States. Most of the debilitating factors related to these diseases are rooted in vascular disorders. The main vascular insufficiencies are associated with vascular plaque formation and thrombus formation that block or decrease blood flow and, as a result, the oxygenated blood supply to these important organs. Medical device technologies and medication treatment are available to mechanically open the arteries or dilate them to avoid heart attack and stroke.
Percutaneous transluminal coronary angioplasty (“PTCA”) was advanced by stents and medicated stents placement. Improvements of these methods are still required, however, to improve diagnosis and treatment of these diseases when they occur. Early detection and prevention of plaque and thrombus formation are needed to lower the incidence of first onset causing infarction and stroke; restenosis post-treatment and the efficacy follow-up of a therapy treatment.
Improvements of these methods are required to improve diagnosis and treatment of these diseases when they occur. Early detection and prevention of plaque and thrombus formation are still needed to lower the incidence of first onset causing infarction and stroke; restenosis post treatment and the efficacy follow-up of a therapy treatment.
There are a number of technologies currently in use for visualizing the lumen of vessels and diagnosing plaque, e.g., radiopharmaceuticals using PET and/or a beta probe, intravascular ultrasound (IVUS), intravascular MRI, intravascular IR, optical coherence tomography (OCT), intravascular temperature changes and their combinations. Different radionuclides are used in myocardial imaging of subjects at rest and after exercise for determining blood flow insufficiencies that indicate stenosis or measurements of other related physiological parameters. Ultrasound is used to image heart wall motion and to measure the blood ejection fraction. MRI imaging and Fast CT scanning are also used to measure similar physiological parameters that indicate stenosis. Direct measurement of plaque in the arteries uses high resolution CT imaging during a simultaneous intra-arterial injection of a contrast media that delineates the area of the narrowing of the artery during the catheterization procedure. OCT visualization of vessel involves the use of complicated and expensive instrumentation as well as the repeated saline washes to view the vessel wall.
In addition, CT, MRI and ultrasound imaging display spatial information differently from CCD light imaging. OCT disclose, in several patents, devices that are aimed at vessels and neoplastic tissue visualization. The utility of these devices is limited due to their complexity and use of mirrors, lens, and light focusing apparatuses required for light reflection propagation and visualization. Furthermore, the wall visualization requires blood washout using repeated saline flushes. Device positioning and registration require delicate and accurate guidewire 13 repositioning such as back and forth movements resulting in difficult therapy deployment.
Current imaging techniques using radiopharmaceuticals using PET and/or a beta probe, intravascular ultrasound (IVUS), intravascular MRI (IVMRI), intravascular IR, OCT, are not optimized. The current IVUS, IVMRI, intravascular IR, and intravascular thermal imaging techniques as well as the current scientific reports of in vivo molecular fluorescence tomography (MTF) (US 2004/0015062 A1 and references therein) do not teach the use of a specific intra-tissue visualization device.
As such, there remains a need for a more inexpensive and sensitive and efficient devices for direct imaging of vessel lumen.